Brigitte Raffeiner PMSc.
Executive Director I Office Management I Clinical Monitor / CRA | Project Manager
+43 699 13386061

Brigitte Raffeiner PMSc.

Curriculum vitae

Education
2003
Competence Certificate Clinical Monitor / CRA, Vienna
2010
University course "Clinical Research", Johannes Kepler University Linz
Work Experience
1990 to 1992
Voest Alpine Stahl Linz GmbH, Department of Research, Development and Test Engineering, Industrial Management Assistant
1992 to 2001
Asamer und Hufnagl GmbH, Office Manager
2002
Mag. Andreas Raffeiner GmbH, Clinical Research Associate

Special skills

Foreign languages
  • German (mother tongue)
  • English (confident in business and discussions)
Computer skills

MS-Office and Internet

Other
  • Performing 'shake tests' for vaccines according to the WHO standards
  • Serving as a local trainer for study data compilation over the Internet (RAVE, RDC, Studymate)
  • Familiarity with the monitor reporting system IMPACT
  • MedDRA- Coding Specialist

Experience

Experience
Phases I - IV
CARDIOLOGY (> 120 patients)
  • Acute coronary syndrome
  • Heart failure
  • Arrhythmia
CENTRAL NERVOUS SYSTEM (> 100 patients)
  • Japanese encephalitis
DERMATOLOGY (> 40 patients)
  • Dermatomyositis
  • Psoriasis
GASTROENTEROLOGY (> 20 patients)
  • Hepatitis C
  • Chronic inflammatory bowel disease
NEPHROLOGY
  • Treatment with Vitamin D derivates during dialysis
ONCOLOGY (> 50 patients)
  • Immunotherapy
  • Ovarian cancer
  • Tubal carcinoma
  • Cervical cancer
  • Peritonealcarcinose
  • Acute myeloid leukaemia
  • Non-small-cell lung carcinoma (NSCLC)
OPHTHALMOLOGY (> 5 patients)
  • Pathologic Myopia
PULMONOLOGY (> 30 patients)
  • COPD
RHEUMATOLOGY (> 5 patients)
  • Rheumatoid arthritis
  • Psoriasis
NON - INTERVENTIONAL STUDIES IN THE CLINICAL THERAPEUTIC AREAS:
  • Rheumatology (200 patients)
  • Dermatology (50 patients)

Training details

Training details
03/17/2003
Seminar diploma: The legal basis of clinical trials
03/24/2003
Seminar diploma: Management and organizational design of clinical trials
03/25/2003
Seminar diploma: Clinical trials from the authorities' perspective
04/01/2003
Seminar diploma: Duties and responsibilities of a monitor
05/06/2003
Certificate of proficiency: Monitor / CRA basis
02/17/2004
Seminar diploma: EU Directive 2001/20/EC on ICH/GCP
05/06/2004 to 05/07/2004
Seminar diploma: Assistants and newcomers in the pharmaceutical industry
07/06/2004
Seminar diploma: No need to fear audits and inspections
03/01/2006 to 03/03/2006
Seminar diploma: The basic principles in medicine 1
03/30/2006 to 03/31/2006
Seminar diploma: The basic principles in medicine 2
12/04/2006
Seminar diploma: Study Management Advanced
09/10/2007
EDC (electronic data capture) Rave Training Version 5.5 EDV
03/03/2008
Seminar diploma: Terminology active word power (Medical English)
04/29/2008 to 09/19/2008
Seminar diploma: Laboratory Values and Laboratory Analysis
09/19/2008
Seminar diploma: Neurology and Psychiatry Workshop, Sophie Förster-Streffleur, MD
10/24/2008 to 10/25/2008
Module: Communication
11/14/2008 to 11/15/2008
Interventional and non-interventional studies
11/28/2008
The Principles of Statistics
11/29/2008
Bibliography search in medical databases
12/19/2008
English for Medical Professionals
02/02/2009
Bioethics
02/03/2009
Ethics Committees
02/04/2009
Medical Law
02/05/2009
Good Clinical Practice
02/06/2009
Introduction to Biostatistics – Mathematical basis
02/20/2009
Seminar diploma: Immunology intensive, Sophie Förster-Streffleur, MD
03/04/2009
Seminar diploma: Medical devices law
03/13/2009
Biostatistics
03/14/2009
Essential documents
03/27/2009 to 03/28/2009
Contract and Insurance Law
04/17/2009
English for Medical Professionals
04/18/2009
Biostatistics
05/15/2009 to 05/16/2009
The Basis of Medicine
06/05/2009 to 06/06/2009
Introduction to Epidemiology
06/10/2009
Seminar diploma: AMG - Amendment 2009
06/19/2009
Ethics - Fraud in Science
06/20/2009
Law—Medicinal Products Act
07/06/2009 to 07/07/2009
Pharmacology
07/08/2009
Biostatistics
07/09/2009
The Basis of Medicine
07/10/2009
Quality Control Monitoring
07/16/2009
Intramural continuing education seminars:
  • Patient Information in Minors/Children
  • News from the seminar "Study Management Advanced"
  • News from the seminar "AMG Amendment 2009"
  • Conduct of a Close out visit
  • Workshop "How can I positively influence the recruiting process?"
09/18/2009
Scientific projects
09/19/2009
Standard Operating Procedures (SOPs)
09/23/2009
Seminar diploma: Pharmacovigiliance concise
10/30/2009
Master thesis-- topic presentation
10/31/2009
Audits
11/13/2009
  • The Basis of Medicine - Psychiatry
  • The Basis of Medicine – Radiation Protection
  • Law and Ethics - Radiation Protection Act
11/14/2009
  • Advanced epidemiology – Dialysis register
  • Law and Ethics
  • Clinical research conducted in Austria in patients who are unable to offer consent
12/04/2009
Quality Assurance - Inspections
01/15/2010
Written exam on:
  • Law and Ethics
  • The Basis of Medicine
  • The Principles of Pharmacology
01/16/2010
  • Medical devices
  • Epidemiology
02/08/2010 to 02/12/2010
Applied Clinical Research
02/26/2010
Intramural continuing education seminars:
  • News from the Seminar "Medicine Products Act"
  • News from the Seminar "Pharmacovigilance Compact"
  • Management Manual Mag. Andras Raffeiner GmbH
03/05/2010
Oral exam, University Course on Clinical Research:
  • Medical Basis
  • Pharmacologic Basis
  • Law and Ethics
03/26/2010
Data Management
04/15/2010 to 04/17/2010
Scientific meeting of the AGO "cancer in woman"
05/07/2010
Seminar diploma: Cardiology Workshop
05/29/2010
Written exam on University Course "Clinical Research"
06/17/2010 to 06/18/2010
Team Seminar Communication, Mag. Erwin Datscher, ProConsult, St. Stefan am Walde
06/19/2010
Oral exam on University Course "Clinical Research"
07/01/2010
Master Thesis - Defence (Professional Master), "Cost Optimization of Clinical Drug Studies - Modern-day Trend or Dangerous tightrope Walk"
09/24/2010
Seminar diploma: Oncology, Beate Mayrbäurl, MD; Linz
03/31/2011
Seminar diploma: Ethics committee in clinical research, Univ.-Prof. Dr. Ernst Singer, Vienna
11/17/2011 to 11/18/2011
Seminar: Coding with MedDRA, Jochen Stecher, MD; Berlin
03/20/2012
Workshop: Stressmanagement, Gabriele Selb, Linz
03/12/2013
Driver Safety Training 1
04/22/2013 to 04/23/2013
Presentation seminar
11/04/2013
Professional teams invest in themselves
04/10/2014
Seminar diploma: mental health at work, Mag. Robert Brandstetter, Faustschlössl, Feldkirchen a.d. Donau
04/11/2014
In-Company training
  • Clinical Trial Regulations, neue EU-Directive
  • ELGA - Elektronische Krankenakte
  • Investigator initiated trials
  • Adaptive Monitoring
  • optimal process of monitoring visits
04/21/2015 to 04/22/2015
Spring Meeting
  • GCP-Findings 2013, FDA-Findings
  • Compassionate Use
  • Medical device law with DI (FH) Dr. Michael Ring
07/20/2015 to 07/21/2015
Summer Meeting

Seminar diploma: Time Management, Mag. Erwin Datscher, Pro Consult

07/21/2015
Training: How to use a fire extinguisher
04/20/2016
Project Management Tools in Clinical Trials, HealthCare Consulting GmbH
09/30/2016
GCP Refresher, QBEX
12/12/2016
Patient Education in Clinical Trials, GxP Konkret
12/16/2016
Setting Limits - Strengthening Resilience, Mag. Manuela Dorninger